Identity
- Trade Name
- Tatum Surgical/One Piece small ball head implant FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- One Piece Dental Implant 3.5mm diameter and 11mm in length small ball head FDA UDI
- Model / Reference
- One Piece/3.5 x 11SB FDA UDI
- Description
- One Piece Dental Implant 3.5mm diameter and 11mm in length small ball head FDA UDI
Identifiers
- Catalog Number
- ITO 3.5 x 11mm (SB) FDA UDI
- Primary DI / UDI-DI
- 00083208235115 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDILength — 11 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
Tatum Surgical/One Piece small ball head implant by Suncoast Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 59af8a02-e432-4625-8f75-74195b4d981b 36 fields · synced May 30, 2026